Debabrata Karmakar
✅Medical Device Complaint Handling Expert ✅ Regulatory Affairs ✅ISO 13485 & FDA 21 CFR 820 ✅ Subject Metter Expert ✅Ex-Cipla ✅Total 7 Years+ experience ✅Open to Quality & Regulatory Opportunities
- Role
- Senior Associate at Wipro
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Debabrata Karmakar
Core Skills & ExpertiseEnd-to-End Complaint Management: Skilled in complaint intake, triage, evaluation, investigation, and closure in compliance with global quality and regulatory standards.Tools & Systems Expertise: Proficient in TrackWise, Salesforce, ARGUS Enterprise, SAP, and Power BI for case management, data analysis, reporting, and documentation.Regulatory & Reporting Knowledge: Experienced in MedDRA coding, eDMR, eDHTR, and FDA MedWatch reporting for serious or reportable events.Complaint Investigations: Strong ability to perform detailed investigations, conduct root cause analysis, assess failure modes, and prepare high-quality technical summaries.Quality & Compliance: Skilled in conducting quality reviews, managing complaint and non-complaint cases, and ensuring compliance with ISO 13485, 21 CFR 803, and global QMS requirements.Cross-Functional Collaboration: Effective in working with manufacturing, quality engineering, service centers, and R&D to gather data and resolve product issues.Trend Analysis & Continuous Improvement: Experienced in analyzing complaint data, identifying trends, and supporting CAPA and process improvement efforts.Leadership & Mentorship: Provided guidance, knowledge transfer, and mentorship to peers; contributed as a Subject Matter Expert (SME) in complaint handling processes.
Experience
Senior Associate
Dec 2022 — Present · Kolkata, IN
Education
Maulana Abul Kalam Azad University of Technology, West Bengal formerly WBUT
Bachelor's degree, Pharmacy
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.